Coronavirus: Ohio study of oral spray faces FDA delay

Four months after an Ohio hospital group announced that it was fast-tracking a clinical trial to see if an antiseptic oral spray could help prevent COVID-19 infections, the study has yet to begin.

University Hospitals in Cleveland, which is working with the Ohio-based creator of the product, sold under the brand name Halo, confirmed last week that the study’s start has been delayed due to U.S. Food and Drug Administration requirements.

“We are rewriting the study protocol in accordance with the FDA’s request,” Lisa Riordan, a spokeswoman for the hospital group, wrote in an email. “The revised protocol will then need to be approved by the FDA. We are not able to predict how long it will take the FDA to approve the revised protocol.”

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When the clinical trial was announced in early April, the principal investigator said it could begin in as little as two weeks, much more quickly than typical trials for medical products.

The goal, Dr. Robert A. Salata said at the time, was to “rapidly determine” whether the oral spray “is effective in providing protection against COVID-19 for frontline health workers.”

The proposal is for the spray to be used by as many as 2,000 of the hospital system’s employees who are in direct contact with COVID-19 patients. The study would determine if the product’s use prevents workers from becoming infected and whether there is a decrease in the duration and severity of upper-respiratory infection in workers who do contract the virus.

Halo has shown promise in preventing influenza and other respiratory illnesses in laboratory studies and in a small clinical trial that Salata supervised at University Hospitals in 2015-16.

Halo had been available over the counter since 2012, but its creator, Cleveland-based ARMS Pharmaceutical, decided to pull it from the market while its effectiveness in preventing COVID-19 infections is investigated. It sold for either $12.99 or $14.99 for a 1-ounce spray bottle.

“While we would like to move forward as expediently as possible, we are committed to working with the FDA as we continue the development” of the oral spray, Afif Ghannoum, president of ARMS Pharmaceutical, said of the testing delay.

Ghannoum, one of the product’s creators, has said he envisioned it as "hand sanitizer for the mouth."

The company developed a formula that uses a common antiviral agent, cetylpyridinium chloride, or CPC, and combines it with an agent that coats the back of the oral cavity and stays in place for at least six hours.

The idea was to create a barrier at the back of the mouth that traps, then kills, viruses and other airborne germs before they enter the respiratory system.

The product’s potential generated so much interest in the northeastern Ohio medical community that the Cleveland Foundation, one of the richest community charitable organizations in the nation, has pledged $1 million in funding for the clinical trial.

jfutty@dispatch.com

@johnfutty